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Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

Primary Purpose

Patients With Cancers, COVID-19, Vaccine

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Coronavirus vaccine

About this trial

This is an interventional treatment trial for Patients With Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age above 18 years
Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included .
Patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ECOG score below 2.
The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion Criteria:

Patients with acute attack of chronic diseases.
Patients have history of convulsion, epilepsy, encephalopathy and psychosis.
Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
Pregnant or lactating women.
Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.
Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Sites / Locations

The Fifth Medical Center of PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coronavirus vaccination

Arm Description

Patients in the experimental need to accept the coronavirus vaccination

Outcomes

Primary Outcome Measures

Safety of coronavirus vaccine

Occurence of adverse effects after COVID-19 vaccination

Immunogenicity of coronavirus vaccine

Titers of anti-SARS-CoV-2 antibodies

Secondary Outcome Measures

Safety of coronavirus vaccine

Occurence of adverse effects after COVID-19 vaccination

Immunogenicity of coronavirus vaccine

Titers of anti-SARS-CoV-2 antibodies

Full Information

NCT ID

NCT05018078

First Posted

August 18, 2021

Last Updated

June 24, 2023

Sponsor

Beijing 302 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05018078

Brief Title

Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

Official Title

The Fifth Medical Center of Chinese PLA General Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 30, 2021 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing 302 Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.

Detailed Description

This study is a prospective, single-arm, open-label clinical trial. A total of 300 patients with different cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Cancers, COVID-19, Vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coronavirus vaccination

Arm Type

Experimental

Arm Description

Patients in the experimental need to accept the coronavirus vaccination

Intervention Type

Biological

Intervention Name(s)

Coronavirus vaccine

Intervention Description

Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

Primary Outcome Measure Information:

Title

Safety of coronavirus vaccine

Description

Occurence of adverse effects after COVID-19 vaccination

Time Frame

Within 2 months after the first dose of coronavirus vaccine

Title

Immunogenicity of coronavirus vaccine

Description

Titers of anti-SARS-CoV-2 antibodies

Time Frame

Within 2 months after the first dose of coronavirus vaccine

Secondary Outcome Measure Information:

Title

Safety of coronavirus vaccine

Description

Occurence of adverse effects after COVID-19 vaccination

Time Frame

Within 13 months after the first dose of coronavirus vaccine

Title

Immunogenicity of coronavirus vaccine

Description

Titers of anti-SARS-CoV-2 antibodies

Time Frame

Within 13 months after the first dose of coronavirus vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age above 18 years Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included . Patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ECOG score below 2. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination. Exclusion Criteria: Patients with acute attack of chronic diseases. Patients have history of convulsion, epilepsy, encephalopathy and psychosis. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy. Pregnant or lactating women. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs. Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fu-Sheng Wang, MD

Phone

8610-66933332

fswang@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ruonan Xu, MD

Phone

8610-66933333

xuruonan2004@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shu-juan Li, MD

Organizational Affiliation

Beijing 302 Hospital

Official's Role

Study Director

Facility Information:

Facility Name

The Fifth Medical Center of PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fu-Sheng Wang, MD

Phone

01066933328

fswang302@163.com

First Name & Middle Initial & Last Name & Degree

Fu-Sheng Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33045429

Citation

Lai CC, Wang JH, Hsueh PR. Population-based seroprevalence surveys of anti-SARS-CoV-2 antibody: An up-to-date review. Int J Infect Dis. 2020 Dec;101:314-322. doi: 10.1016/j.ijid.2020.10.011. Epub 2020 Oct 9.

Results Reference

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PubMed Identifier

32345594

Citation

Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28.

Results Reference

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PubMed Identifier

33930323

Citation

Monin L, Laing AG, Munoz-Ruiz M, McKenzie DR, Del Molino Del Barrio I, Alaguthurai T, Domingo-Vila C, Hayday TS, Graham C, Seow J, Abdul-Jawad S, Kamdar S, Harvey-Jones E, Graham R, Cooper J, Khan M, Vidler J, Kakkassery H, Sinha S, Davis R, Dupont L, Francos Quijorna I, O'Brien-Gore C, Lee PL, Eum J, Conde Poole M, Joseph M, Davies D, Wu Y, Swampillai A, North BV, Montes A, Harries M, Rigg A, Spicer J, Malim MH, Fields P, Patten P, Di Rosa F, Papa S, Tree T, Doores KJ, Hayday AC, Irshad S. Safety and immunogenicity of one versus two doses of the COVID-19 vaccine BNT162b2 for patients with cancer: interim analysis of a prospective observational study. Lancet Oncol. 2021 Jun;22(6):765-778. doi: 10.1016/S1470-2045(21)00213-8. Epub 2021 Apr 27.

Results Reference

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PubMed Identifier

33861303

Citation

Herishanu Y, Avivi I, Aharon A, Shefer G, Levi S, Bronstein Y, Morales M, Ziv T, Shorer Arbel Y, Scarfo L, Joffe E, Perry C, Ghia P. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Blood. 2021 Jun 10;137(23):3165-3173. doi: 10.1182/blood.2021011568.

Results Reference

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PubMed Identifier

33563499

Citation

Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.

Results Reference

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PubMed Identifier

33577086

Citation

Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751.

Results Reference

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Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

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